FDA.reportPublic FDA data

prothrombin complex concentrate (human) 1 UNT Injection

RxCUI
1484958
RxNorm name
prothrombin complex concentrate (human) 1 UNT Injection
Display name
prothrombin complex concentrate (human) 1 UNT Injection
Full name
prothrombin complex concentrate (human) 1 UNT Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:27

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125421KcentraProthrombin Complex Concentrate (Human)351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
eee1afb8-324c-42e4-8bf0-f0c9da5e6d42prothrombin complex concentrate (human) 1 UNT Injection [PSN] · coagulation factor IX, human 1 UNT / coagulation factor X, human 1 UNT / factor VII, human 1 UNT / protein C, human 1 UNT / protein S, human 1 UNT / prothrombin, human 1 UNT Injection [SCD] · prothrombin complex concentrate human 1 UNT Injection [SY]313These highlights do not include all the information needed to use KCENTRA safely and effectively. See full prescribing information for KCENTRA. KCENTRA (Prothrombin Complex Concentrate (Human)) For Intravenous Use, Lyophilized Powder for Reconstitution Initial U.S. Approval: 201320230516